FDA committee votes against Xarelto for ACS-Janssen Pharma

The FDA Cardiovascular and Renal Drugs Advisory Committee has voted against the approval of the use of Xarelto (rivaroxaban), from Janssen Pharmaceuticals, to reduce the risk of thrombotic cardiovascular events in patients with Acute Coronary Syndrome (ACS) in combination with standard antiplatelet therapy. Janssen is seeking approval of rivaroxaban at a proposed dose of 2.5 mg twice daily (BID) for a 90 day treatment duration.

The advisory committee's recommendation was based on review of the 15,526-patient pivotal Phase III ATLAS ACS 2 TIMI 51 clinical trial of rivaroxaban. Results showed that rivaroxaban, in combination with standard therapy, was superior to standard therapy alone in preventing secondary cardiovascular events in patients with ACS. In patients receiving rivaroxaban and standard therapy, rates of Thrombolysis In Myocardial Infarction major bleeding events not associated with coronary artery bypass graft surgery were low overall, yet statistically significantly increased versus those treated with standard therapy plus a placebo. These differences were not associated with an excess risk of fatal bleeding.

In August 2013, Janssen issued a resubmission to the complete response from the FDA for rivaroxaban 2.5 mg twice daily (BID) to reduce the risk of secondary cardiovascular events in patients with ACS for a 90 day treatment duration.